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Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.

ABSTRACT: Despite the high prevalence and global impact of knee osteoarthritis (KOA), current treatments are palliative. No disease modifying anti-osteoarthritic drug (DMOAD) has been approved. We recently demonstrated significant involvement of uric acid and activation of the innate immune response in osteoarthritis (OA) pathology and progression, suggesting that traditional gout therapy may be beneficial for OA. We therefore assess colchicine, an existing commercially available agent for gout, for a new therapeutic application in KOA.COLKOA is a double-blind, placebo-controlled, randomized trial comparing a 16-week treatment with standard daily dose oral colchicine to placebo for KOA. A total of 120 participants with symptomatic KOA will be recruited from a single center in Singapore. The primary end point is 30% improvement in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at week 16. Secondary end points include improvement in pain, physical function, and quality of life and change in serum, urine and synovial fluid biomarkers of cartilage metabolism and inflammation. A magnetic resonance imaging (MRI) substudy will be conducted in 20 participants to evaluate change in synovitis. Logistic regression will be used to compare changes between groups in an intention-to-treat analysis.The COLKOA trial is designed to evaluate whether commercially available colchicine is effective for improving signs and symptoms of KOA, and reducing synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. These biomarkers should provide insights into the underlying mechanism of therapeutic response. This trial will potentially provide data to support a new treatment option for KOA.The trial has been registered at clinicaltrials.gov as NCT02176460 . Date of registration: 26 June 2014.

SUBMITTER: Leung YY

PROVIDER: S-EPMC4434529 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.

Leung Ying-Ying YY Thumboo Julian J Wong Bak Siew BS Haaland Ben B Chowbay Balram B Chakraborty Bibhas B Tan Mann Hong MH Kraus Virginia B VB

Trials 20150430

<h4>Background</h4>Despite the high prevalence and global impact of knee osteoarthritis (KOA), current treatments are palliative. No disease modifying anti-osteoarthritic drug (DMOAD) has been approved. We recently demonstrated significant involvement of uric acid and activation of the innate immune response in osteoarthritis (OA) pathology and progression, suggesting that traditional gout therapy may be beneficial for OA. We therefore assess colchicine, an existing commercially available agent ...[more]

PMID: 25925674

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Project description:BACKGROUND:Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. METHODS:Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ?45 and???80?years, with body mass index ?28?kg/m2 and?<?41?kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12?months. Primary outcomes are self-reported knee pain and physical function at 6?months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. DISCUSSION:This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).

Project description:BACKGROUND:Osteoarthritis (OA) is the most prevalent chronic joint disease, characterized by joint structural deterioration, pain and loss of function among the elders. It is also associated with several extra-articular symptoms (fatigue, sleep disorders, anxiety and depression) and a reduction of life quality. Studies have revealed that patients with OA benefitted from enhanced management via telemedicine. Guangdong Online Hospital (GOH) is the first officially recognized web-based hospital that provides telemedicine service in China. However, the effective implementation of GOH telemedicine (GOHT) to enhance management for patients with OA remains unknown. METHODS/DESIGN:An assessor-blinded, parallel randomized controlled trial will be performed to study the feasibility and effectiveness of GOHT in the enhanced management of OA. Forty participants with knee OA will be recruited for a 6-month study. Patients meeting the inclusion criteria will be randomly allocated to receive conventional therapy (CT) or conventional therapy plus a brief GOH-based intervention (CT-GOHT). The primary outcome is the feasibility of a full-scale randomized controlled trial. The secondary outcomes include the self-reported total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Multidimensional Fatigue Inventory (MFI), the Pittsburgh Sleep Quality Index (PSQI) and the Hospital Anxiety and Depression Scale (HADS). Assessments will be performed at baseline, 2 weeks, 3 months and 6 months later after the initiation of the study. DISCUSSION:This trial is intended to test the application of GOHT in the chronic management in knee OA. The hypothesis is that OA patients may receive disease management via this network platform conveniently and effectively, especially those in the remote areas of our country. GOHT telemedicine would be an attractive alternative to traditional methods for disease management in knee OA. The results could provide preliminary experiences and guidance for an upcoming full-scale randomized controlled trial (RCT) in disease management via telemedicine. TRIAL REGISTRATION:ChiCTR: ChiCTR1800014465 . Registered on 16 January 2018.

Project description:Integrating physical therapy sessions and an online application (e-Exercise) might support people with hip osteoarthritis (OA), knee OA, or both (hip/knee OA) in taking an active role in the management of their chronic condition and may reduce the number of physical therapy sessions.The objective of this study was to investigate the short- and long-term effectiveness of e-Exercise compared to usual physical therapy in people with hip/knee OA.The design was a prospective, single-blind, multicenter, superiority, cluster- randomized controlled trial.The setting included 143 primary care physical therapist practices.The participants were 208 people who had hip/knee OA and were 40 to 80 years of age.e-Exercise is a 3-month intervention in which about 5 face-to-face physical therapy sessions were integrated with an online application consisting of graded activity, exercise, and information modules. Usual physical therapy was conducted according to the Dutch physical therapy guidelines on hip and knee OA.Primary outcomes, measured at baseline after 3 and 12 months, were physical functioning and free-living physical activity. Secondary outcome measures were pain, tiredness, quality of life, self-efficacy, and the number of physical therapy sessions.The e-Exercise group (n = 109) received, on average, 5 face-to-face sessions; the usual physical therapy group (n = 99) received 12. No significant differences in primary outcomes between the e-Exercise group and the usual physical therapy group were found. Within-group analyses for both groups showed a significant improvement in physical functioning. After 3 months, participants in the e-Exercise group reported an increase in physical activity; however, no objectively measured differences in physical activity were found. With respect to secondary outcomes, after 12 months, sedentary behavior significantly increased in the e-Exercise group compared with the usual physical therapy group. In both groups, there were significant improvements for pain, tiredness, quality of life, and self-efficacy.The response rate at 12 months was 65%.The blended intervention, e-Exercise, was not more effective than usual physical therapy in people with hip/knee OA.

Dataset Information

Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.

Publications

Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.

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